D-0568-2024 Class II Terminated
FDA drug recall D-0568-2024 was initiated by Golden State Medical Supply Inc. on May 13, 2024 and is designated Class II. Reason for recall: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit. The recall status is terminated (terminated Mar 20, 2025). Affected quantity: 21,655 (30 count bottle), 34,149 (90 count bottle).
Recall details
- Product Type
- Drugs
- Report Date
- Jul 3, 2024
- Initiation Date
- May 13, 2024
- Termination Date
- Mar 20, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,655 (30 count bottle), 34,149 (90 count bottle)
Product description
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Reason for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Distribution pattern
Nationwide in the U.S.
Code information
Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0568-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026